FDA.reportPublic FDA data

Dextromethorphan Hydrobromide and Quinidine Sulphate

Product NDC
63304-650
Requested package NDC
63304-650-60
11-digit product format
633040650
Labeler code
63304
Product ID
63304-650_5617af8d-e7b7-1c2c-e063-6294a90a7486
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextromethorphan Hydrobromide and Quinidine Sulphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA204196
Marketing category
ANDA
Marketing start
2026-07-30
Substance
DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE
Active strength
20; 10 mg/1; mg/1
Pharmacologic classes
Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204196-001DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATEDEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE20MG;10MGCAPSULE / ORALAB2026-06-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A204196-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A204196-001DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE20MG;10MGCAPSULE / ORALAB2026-06-0384e616aacf4f…
2026-08-18 06:07:402026-07A204196-001DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE20MG;10MGCAPSULE / ORALAB2026-06-03caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204196-001DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE20MG;10MGCAPSULE / ORALAB2026-06-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A204196-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A204196-001AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204196-001AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Dextromethorphan Hydrobromide and Quinidine Sulphate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/1
QUINIDINE SULFATE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
J13S2394HEInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1040054Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92b54ac4-594e-47b8-a4d3-394a29b425f3Available on FDA.report

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dextromethorphan Hydrobromide and Quinidine SulphateDEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULPHATEGolden State Medical Supply, Inc.583de7bd-9b82-5e55-e063-6294a90a0bdf2026-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204196
application number: ANDA204196
Dextromethorphan Hydrobromide and Quinidine SulphateDEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULPHATESun Pharmaceutical Industries, Inc.92b54ac4-594e-47b8-a4d3-394a29b425f32026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204196
application number: ANDA204196
ndc (package): 63304-650-60
ndc (product): 63304-650
ndc11 (package): 63304065060

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63304-650-606330406506060 CAPSULE in 1 BOTTLE (63304-650-60) 60 capsule2026-07-30NoNoCurrent